FDA Registration
Active
🇺🇸 United States
CD HORIZON® Spinal System
Reg #: 1526534
·
FEI: 1526534
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Sterigenics US, LLC
- Registration Number
- 1526534
- FEI Number
- 1526534
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 305 Enterprise Dr
- City
- Lewis Center
- State
- OH
- ZIP
- 43035
- Country
- US
Regulatory Submissions
- 510(k) Number
- K132328
Owner / Operator
- Firm Name
- Sotera Health LLC
- Operator Number
- 10029425
- Address
- 2015 Spring Road, Suite 650
- City
- Oak Brook
- State
- IL
- Postal Code
- 60523
- Country
- US
- Correspondent
- Karen Whaley-Krumins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2018-03-15 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2018-03-15 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2018-03-15 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2018-03-15 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2018-03-15 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2018-03-15 |
Proprietary Names
CD HORIZON® Spinal System
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)